Doctors save baby’s life with 3D-printed tracheal implant

In an article published in the New England Journal of Medicine today, two doctors from the University of Michigan described how they saved an infant with a life-threatening respiratory disorder using a custom-designed 3D-printed device. Printed with bio-absorbable plastic, the device is holding the child's airway open and allowing him to breathe normally.

The child, Kaiba Gionfriddo, suffered from tracheobronchomalacia—a collapse of the airway to one of his lungs. The condition prevented him from breathing out carbon dioxide and getting sufficient oxygen. At six weeks old, he was out with his family at a restaurant when he started to turn blue. By the time he was two months old, he had to have a breathing tube inserted into his trachea to keep him alive.

Dr. Glenn Green, MD, the associate professor of pediatric otolarygololgy at the University of Michigan, was called in by Kaiba's doctors to consult on the case. He and Dr. Scott Hollister, Ph.D., a professor of biomedical engineering at Michigan, worked together to design a tracheal splint for Kaiba, using a CT scan of his respiratory tract to create a model of the device. They obtained emergency clearance from the Food and Drug Administration to surgically implant their creation and installed the splint on the bronchus of Kaiba's left lung on February 9, 2012.

“The material we used is a nice choice for this," Hollister said in a release published by the University of Michigan. "It takes about two to three years for the trachea to remodel and grow into a healthy state, and that’s about how long this material will take to dissolve into the body.”

A University of Michigan video detailing Kaiba Gionfriddo's case and the creation of the 3D-printed tracheal splint.

The FDA will only get involved if a device is marketed. There is nothing to prevent physicians from using medications that are FDA approved for non-approved uses (called "off label use"), or from using their ingenuity to craft unique solutions to unique physical/surgical problems.

If the doctor were to try to market and mass produce this, he'd have to submit to clinical trials. A one shot deal the FDA doesn't get involved in; the FDA does not regulate the practice of medicine.

Wow, you are getting down voted for posting the very same thing I was going to post. Unless these guys are down voting you for 3d pizza? This was an awesome use of 3d printing as you said a positive use, saving a life.

The FDA will only get involved if a device is marketed. There is nothing to prevent physicians from using medications that are FDA approved for non-approved uses (called "off label use"), or from using their ingenuity to craft unique solutions to unique physical/surgical problems.

If the doctor were to try to market and mass produce this, he'd have to submit to clinical trials. A one shot deal the FDA doesn't get involved in; the FDA does not regulate the practice of medicine.

The article mentioned emergency clearance by the FDA. AFAIK, in the USA, the FDA does regulate items that get implanted into humans by licensed physicians, whether or not they're being marketed.

Awesome use of a new technology! Something troubles me about this though - what if the implanted object had to be produced as an emergency measure DURING a surgical procedure? Is there some mechanism whereby the FDA would not have to be consulted if it could mean the difference between life & death? Given the superb potential of custom crafted 3D objects to be designed & used for specific patients' needs during specific operations, is there some caveat to FDA regs that would cover this situation?

The FDA will only get involved if a device is marketed. There is nothing to prevent physicians from using medications that are FDA approved for non-approved uses (called "off label use"), or from using their ingenuity to craft unique solutions to unique physical/surgical problems.

If the doctor were to try to market and mass produce this, he'd have to submit to clinical trials. A one shot deal the FDA doesn't get involved in; the FDA does not regulate the practice of medicine.

The article mentioned emergency clearance by the FDA. AFAIK, in the USA, the FDA does regulate items that get implanted into humans by licensed physicians, whether or not they're being marketed.

I can support this claim as someone involved in the medical field. Implantable devices are highly regulated.

VERY clever and amazing integration of cutting edge technology into medicine in an emergent situation. Not something you see many physicians willing to risk with the current malpractice laws in many states. Amazing work.

The FDA will only get involved if a device is marketed. There is nothing to prevent physicians from using medications that are FDA approved for non-approved uses (called "off label use"), or from using their ingenuity to craft unique solutions to unique physical/surgical problems.

If the doctor were to try to market and mass produce this, he'd have to submit to clinical trials. A one shot deal the FDA doesn't get involved in; the FDA does not regulate the practice of medicine.

The article mentioned emergency clearance by the FDA. AFAIK, in the USA, the FDA does regulate items that get implanted into humans by licensed physicians, whether or not they're being marketed.

I can support this claim as someone involved in the medical field. Implantable devices are highly regulated.

VERY clever and amazing integration of cutting edge technology into medicine in an emergent situation. Not something you see many physicians willing to risk with the current malpractice laws in many states. Amazing work.

As with drugs, devices must go through extensive and expensive safety and effectiveness testing, (still not always enough!) prior to marketing. Typically through a teaching hospital review board with animals before any human trials are done.

3D printing is something I highly approve my tax dollars being funneled into research for. This story alone makes it worth the investment.

As with the cell phone and the internet, 3D printing will eventually be one of the technologies that change the world. I'm very much hoping NASA helps develop the technology for printing food. It would be amazing to know we live in a world where nobody on Earth will starve, yet also allow for humans to be one step closer to exploring the solar system.

Thanks to the doctors that thought of this and thanks to the FDA for fast tracking the use of the device in this way.

It seems we're witnessing the dawn of a new economic era where the 3D printers will shift a lot of the manufacturing from large factories to smaller entities and households.

Yea it's pretty awesome! too bad US lobbies will buy laws in Congress that will pretty much kill the free distribution of 3D models over the internet and will most probably throttle the technology with DMCA like regulation and DRM, all in an attempt to keep the status quo of old business models.

It's not just keeping his airways open, from the sounds of it this'll actually result in the trachea being able to repair itself and it won't require surgery to remove it at a later date either unless something goes wrong. That's just as awesome as the fact it was 3D printed, less surgery for the kid to have to live through

Not sure why people wanted to down vote your post, I guess they may not have realized the intelligence in that simple statement.

That's a very valid 'surprise' point actually. The FDA emergency approved basically for or based upon four reasons/principals in consideration, parts of the same basic principals they consider in the thought process for all emergency approvals under FDA compassionate use rules to save a life. The first principal being safety, a bio-absorbable plastic was used which has already been in use within the medical area and known to be safe, and the procedure can be accomplished safely. The second principal being commonality to existing medical process/procedure, the application/methodology/theory use of such devices/methods (not necessarily this particular device) is not that uncommon, for example, stints used for heart arteries (in the opening artery up aspect and known to be safely beneficial to health and life), and tracheal implants have already been approved (the first one done in the U.S. basically used the patients own stem cells to produce tissue over a plastic scaffold and others have been done since 2008 http://www.burrillreport.com/article-fi ... tates.html), so there is existing commonality. The third principal being the life/health impact and medical necessity, it was an 'immediately available' life saving measure and there is beneficial health and life saving commonality with already existing medical use. The fourth principal being any possible adverse risk from use of the device was deemed far less than the alternative of life threatening impact without it and thus use is beneficially compassionate as a life saving measure. The FDA approval has nothing to do with the production of the device being by a 3D printing technique, if the device had been manufactured via more conventional techniques and was available at the time it could have been used also and would have been emergency approved.

What should be applauded here is not the 3D printing technique used, because this device could have been produced by other existing methods. Rather, what should be applauded is the doctors ingenuity in determining an immediately available health and life saving measure.

The uniqueness of being able to 3D print such 'medically necessary' things on demand instead of manufacture via more conventional techniques does raise a few interesting questions though.

In conventional 'supply' manufacture things like this are regulated and adhere to certain standards. So what happens when a loose undefined cottage industry to which regulation and quality standards can not be applied or are difficult to apply, springs up 3D printing medical critical use devices and they start finding their way into the medical market?

What happens when the patent wars start over such 3D printable medical devices? We've already seen how paralyzing it is to other areas when patent violation cases start flowing. What happens when supply of 3D printable medical devices is curtailed or affected by such patent related actions after (and if) 3D printing of such devices becomes more the norm?

Wow, you are getting down voted for posting the very same thing I was going to post. Unless these guys are down voting you for 3d pizza? This was an awesome use of 3d printing as you said a positive use, saving a life.

Downvotes are probably from people being pissy about the guns comment. How dare society make something that can be used to kill into something that can save a life.

It seems we're witnessing the dawn of a new economic era where the 3D printers will shift a lot of the manufacturing from large factories to smaller entities and households.

This case is great news, and it's a major victory for medicine.

However, I disagree with you. I think that biological grafts are probably one of a very small number of really useful cases for 3d printing. How many objects in your house are only made of a single type of material- polymer at that? Pencaps and child-proof plates and not a whole lot else. In order to bring a new economic era of decentralized production, we're going to need something that looks a lot more like a universal nano-assembler/disassembler. And it's not even clear that such a technology is even possible.

Awesome use of a new technology! Something troubles me about this though - what if the implanted object had to be produced as an emergency measure DURING a surgical procedure? Is there some mechanism whereby the FDA would not have to be consulted if it could mean the difference between life & death? Given the superb potential of custom crafted 3D objects to be designed & used for specific patients' needs during specific operations, is there some caveat to FDA regs that would cover this situation?

As far as I know (ianad), they rarely open someone up to do reconstructive work without know what to expect before going. If it's exporatory surgery, they'd probably close the patient back up then plan what to do. You don't want to leave someone open on the operating table while you figure out what to do. And with the plethora of imaging options available, it's become possible to do that, like in this example. In this example, the device is precision made to fit the specific patient; you can't get the measurements to do that while they're on an operating table.

I feel sorry for that kid. Unable to go out and play for 2-3 years with that thing, because it looks like one good fall would cause serious damage to the implant.

What are the alternatives? Death? A breathing tube? They're not very fun either, and the breathing tube is much more invasive. And I'm sure the doctocs have reviewed acceptable levels of activity with the parents. Who knows, maybe he can have a (more or less) normal life, even with the implant.

Wow, you are getting down voted for posting the very same thing I was going to post. Unless these guys are down voting you for 3d pizza? This was an awesome use of 3d printing as you said a positive use, saving a life.

Downvotes are probably from people being pissy about the guns comment. How dare society make something that can be used to kill into something that can save a life.

Glad to see such an amazing use of the technology.

Yes, and glad to see positive articles being posted by Ars and elsewhere. There are too many knee-jerk reaction people in government and elsewhere that heard the 3D gun issue and immediately associated this technology with something "bad" in their opinion. In the end they are just mounting another anti-technology anti-progress campaign. Hopefully with enough of this positive info enough of these people will open their minds to possibilities for this tech that aren't against their personal or political beliefs. Any technology and any thing can be put to positive or negative use. Banning a technology will not stop bad people.

I feel sorry for that kid. Unable to go out and play for 2-3 years with that thing, because it looks like one good fall would cause serious damage to the implant.

BTW, the big branching thing is *NOT* the implant: that's a model of the kid's trachea/bronchi stuff (yah, I'm not a biologist). The implant is a little sleeve that goes on the pinch point on the right branch (see a better picture set here: http://www.engadget.com/2013/05/23/3d-p ... al-splint/ )

This is such a cool story - it's always awesome to see uses of 3D printers that aren't frivolous crap like models of Yoda.

It's odd to me to see the kid's name is Kaiba, though, since that's my cat's name (same spelling, too!) I wonder if his parents named him after drinking too much and watching Yu-Gi-Oh! the Abridged Series like I did.

Wow, you are getting down voted for posting the very same thing I was going to post. Unless these guys are down voting you for 3d pizza? This was an awesome use of 3d printing as you said a positive use, saving a life.

Downvotes are probably from people being pissy about the guns comment. How dare society make something that can be used to kill into something that can save a life.

Glad to see such an amazing use of the technology.

Yes, and glad to see positive articles being posted by Ars and elsewhere. There are too many knee-jerk reaction people in government and elsewhere that heard the 3D gun issue and immediately associated this technology with something "bad" in their opinion. In the end they are just mounting another anti-technology anti-progress campaign. Hopefully with enough of this positive info enough of these people will open their minds to possibilities for this tech that aren't against their personal or political beliefs. Any technology and any thing can be put to positive or negative use. Banning a technology will not stop bad people.

3D printing is poised to change manufacturing and the entire concept of supply and demand. It would be much better if we embrace it now and guide its evolution, rather than shun it and fall behind. I don't see any reason why today's manufacturing industry cannot take advantage of 3D printing now. Maybe you can't make finished products, but you could certainly make smaller sub components that would normally be bought in. In time this usage would help shape the future of 3D printing.

I mean if you think about it 3D printers are the next step from CNC mills, which have been around for over 50 years. Next step is 3D printing metal.

I don't think the problem for many people is 3D printing itself but the potential abuse for using it. Not just guns but other forms of weapons or malicious use. Things like this show that there is a positive upside to the technology. Saving lives over taking them shouldn't earn a down vote.

Sean Gallagher / Sean is Ars Technica's IT Editor. A former Navy officer, systems administrator, and network systems integrator with 20 years of IT journalism experience, he lives and works in Baltimore, Maryland.